Study on "Essen Plant Protein" - A nutritional powdered supplement for active adults (exercisers, gym goers) for protein supplementation. The Protein is vegan - plant based protein only.

Phase 3

Completed

Conditions: Clinically Healthy Physically Active Adults

Registration Number: CTRI/2022/07/043981

Lead Sponsor: Essen Fooddies India Pvt Ltd

Brief Summary: **Study Design :** Open Label, Prospective, Non-Randomised, Non-Comparative, Two Arm Clinical Study

**Indication :** Plant Based Nutritional Supplement for Clinically Healthy Physically Active Adults

**Investigational Product Details** Name : Essen Plant Protein : Unflavoured Route of Administration : Oral Dose : 29g (3 heaped scoops) in 500ml of water Dosage : OD for 3 months

Name : Essen Plant Protein : Chocolate Flavoured Route of Administration : Oral Dose : 35g (6 levelled scoops) in 500ml of water Dosage : OD for 3 months

**Subject Population :** Clinically healthy adult subjects between the ages of 40 and 65 years (both ages and all genders inclusive)

**Treatment Arms :** Two. Non Comparative Single Arm Study Treatment Arm I : Unflavoured Essen Plant Protein Treatment Arm II : Chocolate Flavoured Essen Plant Protein

**Number of Subjects :** 35 Subjects

**Efficacy Assessments:** 1. Stair Climbing Test : Day 1, Day 45, Day 90 2. 30 Second Chair Stand Test : Day 1, Day 45, Day 90 3. Borg Rating of Perceived Exertion : Day 1, Day 45, Day 90 4. Hand Grip Strength using Dynamometer : Day 1, Day 45, Day 90

**Safety Assessments:** 1. Clinical Safety : CBC, Serum Biochemistry 2. Monitoring of Adverse Events

**Background of the Study :**A nutritional state resulting from an inadequate intake of nutrients, particularly in energy (though also protein and micronutrients), leads to reduced mass, reduced requirement, reduced work, physiologic and metabolic changes, changes in the body composition and loss of tissue reserve. Oral nutritional supplements can be prescribed to supply one or more nutrient deï¬ciencies and restore the proper development and function of the body. The aim of such products is to supplement everyday diet with nutrients in an effort to elevate the health status in adults.

**Purpose of the Study** : **Essen Plant Protein** is a plant based supplement by Essen Fooddies Pvt. Ltd with key ingredients that have been researched in improving general health in clinically healthy adults. This clinical study is designed as an Open Label, Prospective, Randomised, Non Comparative, Two Arm Clinical Study to Evaluate the Effectiveness, Safety and Tolerability of â€œEssen Plant Proteinâ€ of Essen Fooddies India Pvt. Ltd as a Nutritional Supplement in in physically active Adults.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 35

Inclusion Criteria

1.Clinically healthy Physically Active Adults between the ages of 40 and 65 years (both ages and all genders inclusive).
2.Subjects who are willing to abstain from use of herbal, allopathic or other nutritional supplements that are indicated at improving general health, strength and performance 3.Subjects who are not on rapid weight loss programs such as but not limited to keto, paleo, warrior, caveman diets.
Intermittent fasting is permitted.
4.Subjects who have scored 12-14 in Mini Nutritional Assessment MNA-SF Questionnaire at the time of screening.
5.Subjects who are physically active i.e walk/cycle/perform other cardio activities for 30 minutes 3 times a week).
6.Subjects who are willing to give informed consent for participation, able to comprehend and understand the responsibilities during screening and treatment period.
7.Subjects who are willing not to participate in any other clinical trial during participation in the current trial.

Exclusion Criteria

1.Subjects with known hypersensitivity to the ingredients of the investigational product 2.Subjects who have an active infection, disease or disorder that will prevent them from fully satisfying the responsibilities of the study.
3.Subjects with history of seizures, uncontrolled diabetes, hypertension or major cardiac illness like congestive heart failure etc.
4.Subjects on remission from cancer of any type less than 5 years at the time of screening 5.Subjects who are planning a pregnancy and/or currently breastfeeding.
6.Subjects who have participated in a clinical study less than 1 month before screening 7.Any significant medical condition (e.g., significant psychiatric or neurological disorders, active alcohol/drug abuse, etc.), any medical condition that is unstable/poorly controlled or other factor (e.g., planned relocation) that the Investigator felt would interfere with study evaluations and study participation.
8.Subjects who mentally unable to comprehend the responsibilities and adhere to the stipulations of the protocol.
9.Subjects, who in the opinion of the Investigator are not eligible for enrolment in the study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Stair Climbing Test : Increase of 10% from baseline	1. Stair Climbing Test : Day 1, Day 45, Day 90 \| 2. 30 Second Chair Stand Test : Day 1, Day 45, Day 90 \| 3. Borg Rating of Perceived Exertion : Day 1, Day 45, Day 90 \| 4. Hand Grip Strength using Dynamometer : Day 1, Day 45, Day 90
3. Borg Rating of Perceived Exertion : Decrease of 3 scores from baseline	1. Stair Climbing Test : Day 1, Day 45, Day 90 \| 2. 30 Second Chair Stand Test : Day 1, Day 45, Day 90 \| 3. Borg Rating of Perceived Exertion : Day 1, Day 45, Day 90 \| 4. Hand Grip Strength using Dynamometer : Day 1, Day 45, Day 90
2. 30 Second Chair Stand Test : Increase of 10% from baseline	1. Stair Climbing Test : Day 1, Day 45, Day 90 \| 2. 30 Second Chair Stand Test : Day 1, Day 45, Day 90 \| 3. Borg Rating of Perceived Exertion : Day 1, Day 45, Day 90 \| 4. Hand Grip Strength using Dynamometer : Day 1, Day 45, Day 90
4. Hand Grip Strength using Dynamometer : Increase of 10% from baseline	1. Stair Climbing Test : Day 1, Day 45, Day 90 \| 2. 30 Second Chair Stand Test : Day 1, Day 45, Day 90 \| 3. Borg Rating of Perceived Exertion : Day 1, Day 45, Day 90 \| 4. Hand Grip Strength using Dynamometer : Day 1, Day 45, Day 90

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (1): Raam Clinic
🇮🇳
Chennai, TAMIL NADU, India
Raam Clinic
🇮🇳Chennai, TAMIL NADU, India
Dr VT Sriraam
Principal investigator
9840909155
md@auroushealthcare.com